Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-01-04 @ 8:33 AM
Study NCT ID:
NCT00224159
Status:
COMPLETED
Last Update Posted:
2011-02-21
First Post:
2005-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Statin Initiation Undermine Dietary Behavior?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2006-06'}, 'lastUpdateSubmitDate': '2011-02-18', 'studyFirstSubmitDate': '2005-09-20', 'studyFirstSubmitQcDate': '2005-09-20', 'lastUpdatePostDateStruct': {'date': '2011-02-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'How drug or dietary therapy may play a role in dietary behavior.'}]}, 'conditionsModule': {'keywords': ['Statin therapy', 'Dietary behavior', 'Attitudes and beliefs', 'Self efficacy'], 'conditions': ['All English Speaking Adults From the Manhattan VA Clinic Who Have Recently Received Their First Prescription for a Statin']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to improve our understanding of the effects that taking cholesterol reducing pills have on dietary behavior as well as other health related behaviors', 'detailedDescription': 'This study explores the impact of initiating statin therapy on subsequent dietary as well as other lifestyle beliefs, attitudes and behaviors.\n\nSpecific aims:\n\n1. To test whether the initiation of statin therapy increases dietary saturated fat intake among statin naive patients.\n2. To determine what role attitudes, beliefs, expectations, motivation, intention and self-efficacy regarding drug or diet therapy may play in observed changes in dietary behavior after starting statin therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All English-speaking adults who have recently (within 1 week)received their first prescription for a statin will be eligible.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll English-speaking adults who have recently (within 1 week)received their first prescription for a statin will be eligible.\n\nExclusion Criteria:\n\nWill include a history of any of the following:\n\n1. Prior CVD (myocardial infarction, angina, angioplasty, stroke, CABG. or arterial bypass surgery)\n2. Diabetes patients\n3. Psychiatric patients\n4. AIDS patients\n5. Substance abuse patients\n6. Prior cholesterol lowering medication use\n7. Inability to complete the interviews'}, 'identificationModule': {'nctId': 'NCT00224159', 'briefTitle': 'Does Statin Initiation Undermine Dietary Behavior?', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Does Statin Initiation Undermine Dietary Behavior?', 'orgStudyIdInfo': {'id': '00710'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Drug and Dietary behavior', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'The New York Presbyterian Hospital-Weill Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Sundar Natarajan, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}, {'name': 'Devin Mann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}]}}}